Brief description of trial (Data source: BASEC)
Aversives Lernen liegt Erkrankungen wie der spezifischen Phobie oder der posttraumatischen Belastungsstörung zugrunde. In dieser Studie wollen wir untersuchen, ob sich durch das Antibiotikum Doxycyclin das aversive Gedächtnis beeinflussen lässt. Doxycyclin wirkt nach Einnahme kurzfristig auf Eiweisse im Gehirn, die wahrscheinlich auch für die Gedächtnisbildung verantwortlich sind. 560 gesunde Probanden bekommen in dieser Studie entweder eine Dosis von 200 mg Doxycyclin oder eine identisch aussehende unwirksame Substanz (Placebo). Die Zuordnung erfolgt zufällig (randomisiert). Weder Ihnen noch uns ist während der Durchführung der Studie bekannt, ob Sie Doxycyclin oder die unwirksame Substanz erhalten (Doppelverblindung)
Health conditions investigated(Data source: BASEC)
Wir führen diese Studie durch, um die Gehirnmechanismen kennenzulernen, die das aversive Gedächtnis beim Menschen steuern. Aversives Gedächtnis ist ein Modell für Angsterkrankungen wie z. B. spezifische Phobien.
Health conditions
(Data source: WHO)
healthy subjects
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Wir untersuchen das Antibiotikum Doxyclin, das zur Malariaprophylaxe auch von gesunden Menschen häufig eingenommen wird. Diese Substanz wirkt möglicherweise auf die Aktivität gedächtnisrelevanter Eiweisse im Gehirn ein.
Interventions
(Data source: WHO)
Group 1: Vibramycin? Tabs (Doxycyline), 200mg capsule, oral administration, single-dose.
6 experiments will examine whether aversive memories of healthy participants can be influenced by the antibiotic doxycycline. The experiments will be conducted over the time span of several days, however, the medicament will only be taken once, either at the time of memory consolidation or reconsolidation.
Group 2: Placebo Mannitol PhEur (Perlitol 200SD)
200mg capsule, oral administration, single-dose
Criteria for participation in trial
(Data source: BASEC)
Es können alle gesunden Personen zwischen 18 und 40 Jahren teilnehmen.
Exclusion criteria
(Data source: BASEC)
(1) Aktuelle Erkrankung.
(2) Frühere neurologische, psychiatrische oder systemische Erkrankung
(3) Aktueller oder früherer regelmässiger Gebrauch von abhängig machenden Substanzen (z. B. Alkohol oder Drogen).
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: 40 Years
Minimum age: 18 Years
Inclusion criteria: - Informed Consent as documented by signature
- Age 18 ? 40 years
Exclusion criteria: ? Allergy to doxycycline or to any other ingredient in the named drugs
? Use of any drugs in the 2 weeks prior to the study with the exception of contraceptive drugs and incidental use of NSARs or paracetamol
? Women who are pregnant or breast feeding,
? Intention to become pregnant during the course of the study,
? Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration
? Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
? Any history of psychiatric, neurological, addiction, or systemic/rheumatic disease
? Known or suspected non-compliance, drug or alcohol abuse
? Inability to follow the procedures of the study, e.g. due to language problems
? Participation in another study with investigational drug within 30 days preceding and during the present study,
? Previous enrolment into the current study,
? Members of the study team and their family members and dependants
? Regular work in a medical profession
? Life time history of being a victim of interpersonal violence or other potentially traumatic experience, or close relative of a person with such history
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Further information on trial
Date trial registered
Nov 5, 2019
Incorporation of the first participant
Oct 29, 2019
Recruitment status
Recruiting
Academic title
(Data source: WHO)
A randomised, double-blind, placebo-controlled study on the impact of doxycycline on aversive memory in healthy individuals - DoxAv
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: basic science
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Primary endpoints are updated prompt to the start of a new experiment.
Experiment 1 and 2:
Fear-potentiated startle, measured via eyeblink EMG of the M. orbicularis oculi and quantified according to Khemka et al. (2017)
Detailed analysis plan: https://osf.io/6kj5u/.
Experiment 5:
Quantity and distress of intrusion in an intrusion diary during one week following the trauma film
Secundary end point
(Data source: WHO)
Experiment 1 und 2:
SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), pupil reaction, neuropsychological tests (e.g. VLM-T), questionnaires (STAI).
Experiment 5:
Questionnaires (e.g. STAI, BIS-BAS), SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), neuropsychological tests (e.g. VLM-T).
Contact information
(Data source: WHO)
Universit?t Z?rich
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
Yes
The anonymised data (behavioural, psychophysiological and demographic data) will be publicised on zenodo.org after publication.
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Erich Seifritz
+41443842312
erich.seifritz@bli.uzh.ch
Contact for general information
(Data source: WHO)
Jelena
Wehrli
Lenggstrasse 31
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
+41 44 384 26 60
jelena.wehrli@bli.uzh.ch
Contact for scientific information
(Data source: WHO)
Birgit
Kleim
Lenggstrasse 31
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
+41 44 384 23 51
b.kleim@psychologie.uzh.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
16.05.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-01973
Secondary ID (Data source: WHO)
SNCTP000003485
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